Electronic assay apparatus, method and kit thereof

ABSTRACT

The present invention related to an electronic assay apparatus and a testing method thereof. The electronic assay apparatus for determining a result of an assay performed using a test strip comprises three light sources, only one detector and a microprocessor. The three light sources respectively illuminate light incident upon three different zones of the test strip. The detector detects light from the three zones alternately and the distances between the only one detector and the three light sources respectively are almost the same. Further, multiple openings corresponding to the three light sources respectively have the same size and/or shape. The microprocessor compares a calculating result value to only one threshold for showing a result.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to an electronic assay apparatus, atesting method, and a kit thereof for quickly and easily reading assayresult.

Description of the Related Art

Lateral flow test strips are known in the art and may be used inclinical diagnosis to determine the presence of an interested analyte ina sample, such as bodily fluid. For example, a lateral flow test stripsuitable for the measurement of the pregnancy hormone human chorinicgonadotropin (hCG) is widely commercially available. The test stripusually has a control zone for determining the work of the assay and hasa testing zone for determining the present of the interested analyte.However, such widely commercially available strips require the result tobe interpreted by the user. Sometimes the result will be erroneous dueto a degree of subjectivity, for example, different people may obtaindifferent test results especially when a single color test zone is lightand blur, which is undesirable.

Electronic assay apparatuses for reading the result of the test stripsare known, according to the matters disclosed in U.S. Pat. No.7,239,394. A conventional electronic assay apparatus includes a teststrip and a circuit broad. The test strip is positioned related to thecircuit broad and has a control zone and a test zone. The circuit broadincludes a microprocessor, three light sources disposed thereon and twolight detectors correspondingly disposed beneath the first light sourceand the third light source, respectively. The control zone and the testzone are aligned to the first and the third light sources respectivelyso as to allow the light from the source to illuminate on respectively.The second light source illuminates a reference zone between the controlzone and the test zone to obtain a background. The first light detectordetects light reflected from the control zone and some of the referencezone and the second light detector detects light reflected from some ofthe reference zone and the test zone. The microprocessor receives adetection signal from the light detectors for determining responsecircumstances of the control zone and the test zone. Furthermore, themicroprocessor also detects the rate of the change of the reading withrespect to time, or d(reading)/d(time) to calculate the result.Alternatively, the rate of change of slope with respect to time may bemeasured or calculated by d²(reading/d)time)². The result is positivewhen the reading value exceeds an upper threshold and is negative whenthe reading value lowers a lower threshold.

Furthermore, besides the determination of a single analyte, some testsneed to detect over two kinds of analytes at the same time or thedetermination which can measure the high and the low concentrations of asingle analyte simultaneously is designed for improving the sensitivityof the determination. According to the known method disclosed in U.S.Pat. No. 7,879,624 ('624), the determination is implemented on two teststrips. The two test strips absorb a sample from the same sample pad,and each test strip has an individual test zone respectively. Thecooperative electronic assay apparatus has different light sources toilluminate light upon a test zone, a control zone and a reference zoneof each test strip and be received by a detector to obtain a result foravoiding the erroneous judgment from the user. However, said detectingmethod of using two test strips has some defects. Not only the test zoneof each test strip needs to be made respectively during manufacturingbut the two test strips should be linked together to the same samplepad. The defects said above may increase the manufacture cost andcomplicate the process which will also affect the yield rate. Thus, aneed exists for improved electronic assay apparatus.

SUMMARY OF THE INVENTION

According to one aspect of the present invention is to provide anelectronic assay apparatus that comprises light sources withpredetermined positions and detector to achieve results reading.

Furthermore, the present invention provides an electronic assayapparatus for improving the known design of the two test stripdetection. The apparatus comprises only one detector and three lightsources, and all of them arranged within a fan-shaped region. Thedetector positioned at the center of circle, and the three light sourcespositioned anywhere upon the arc of a sector whose circle center is thesaid detector. By this way, the size of test strips could be smaller andto avoid the erroneous judgment caused by that both the two test stripsused the only one control zone and reference zone. Moreover, that couldalso avoid the possibility of the incomplete flow of the sample due tothat both of the two test strips use a single sample pad.

For achieving the objective said above, one skilled method of thepresent invention is providing an electronic assay apparatus fordetermining a result of an assay, the apparatus comprises:

-   -   three light sources are aligned for respectively illuminating        light incident upon three spatially separated zones of the test        strip, wherein the three zones include a test zone, a control        zone and a reference zone;    -   only one detector to detect light from the three different zones        of the test strip and receive the corresponding signals which        include a test zone signal, a control zone signal and a        reference zone signal, wherein the distances between the only        one detector and the three light sources respectively are almost        the same; and    -   a microprocessor for receiving the signals from the detector and        calculating the signals to a result value relating to the test        zone signal and the reference zone signal;    -   wherein the microprocessor compares the result value to a        threshold and generates an output signal, if the result value        exceeds the threshold and indicative of a first result, or,        alternatively, the output signal indicative of a second result        if the result value is less than the threshold.

In a preferred embodiment in accordance with the present invention, thepositions of the detector and the three light sources may be designed toarrange within a fan-shaped region. The detector positioned at a centerof circle, and the three light sources positioned anywhere upon the arcof a sector whose circle center is the said detector.

In a preferred embodiment in accordance with the present invention, thetest strip further includes a second test zone, and the electronic assayapparatus further comprises a fourth light source for illuminating lightincident upon the second test zone. Preferably, the second test zone andthe test zone are used to detect different analytes or differentconcentrations of a single analyte.

In a preferred embodiment in accordance with the present invention, thedetector and the four light sources could be designed to arrange withina fan-shaped region. The detector positioned at a center of circle andthe four light sources positioned anywhere upon the arc of a sectorwhose circle center is the said detector.

In a preferred embodiment in accordance with the present invention, theapparatus preferred further comprises a baffle which comprises aplurality of shelters defining a plurality of openings corresponding tothe light source and the detector respectively. The baffle used to blockinterferences from outside light source or between the internal lightsources. The baffle further comprises a blocker positioned at thesuitable site of the detector and is used to block direct light from thelight sources. Pluralities of slits are defined between the blocker andthe shelters, and for permitting the detector to detect the reflectedlight from the different zones of the test strip respectively. Multipleopenings corresponding to the three light sources respectively may havethe same size and/or shape.

The apparatus in accordance with the present invention preferablyfurther comprises an ejective element and a switch. The ejective elementused to orientate and eject the test strip. When the ejective elementorientates the test strip and then opens the switch, the microprocessoris further activated and turns on the electronic assay apparatusautomatically. By this, the user would turn on or off the apparatusautomatically through no buttons.

In a preferred embodiment in accordance with the present invention, thebaffle further comprises a trigger. The trigger opens the switch whenthe ejective element orientates the test strip and then makes the teststrip to contact the trigger.

Another aspect of the present invention provides an electronic assayapparatus for determining a result of an assay, the apparatus comprises:

-   -   three light sources are aligned for respectively illuminating        light incident upon the three spatially separated zones of the        test strip;    -   only one detector to detect the reflected light from the three        zone of the test strip and obtain the corresponding signals,        wherein the detector and the three light sources are arranged        within a fan-shaped region, the detector positioned at a center        of circle, and the three light sources positioned anywhere upon        the arc of a sector whose circle center is the said detector;        and    -   a microprocessor for receiving the signals from the detector and        calculating the signals to obtain a result value;    -   wherein the microprocessor compares the result value to a        threshold and generates an output signal, if the result value        exceeds the threshold and indicative of a first result, or,        alternatively, the output signal indicative of a second result        if the result value is less than the threshold.

In a preferred embodiment in accordance with the present invention, thethree light sources comprise:

-   -   a first light source illuminating light incident upon a test        zone of the test strip;    -   a second light source illuminating light incident upon a control        zone spatially separated from the test zone of the test strip;    -   a third light source illuminating light incident upon a        reference zone spatially separated from the test zone of the        test strip; and    -   further comprising a fourth light source illuminating light        incident upon a second test zone spatially separated from the        test zone of the test strip, wherein the test zone and the        second test zone are used to detect different analytes or        different concentrations of a single analyte.

Another aspect of the present invention provides an electronic assayapparatus for determining a result of an assay, the apparatus comprises:

-   -   three light sources are aligned for respectively illuminating        light incident upon the three spatially separated zones of the        test strip;    -   only one detector to detector the reflected light from the three        different zones of the test strip and obtain the corresponding        signals, wherein the detector and the three light sources are        arranged within a fan-shaped region, the detector positioned at        a center of circle, and the three light sources positioned        anywhere upon the arc of a sector whose circle center is the        said detector.

Still another aspect of the present invention provides an electronicassay apparatus for determining the performances of at least one analytein a sample, the apparatus comprising:

-   -   a test strip with a single flow direction and comprising a test        zone, a control zone and a reference zone, wherein the test zone        for fixing a substance reacting with the analyte and displaying        the performance of the analyte;    -   three light sources are aligned for respectively illuminating        light incident upon the test zone, the control zone and the        reference zone of the test strip;    -   only one detector to detect the reflected light from the test        zone, the control zone and the reference zone of the test strip        and obtain the corresponding signals proportion to the        concentration of the analyte, wherein the detector and the three        light sources are arranged within a fan-shaped region, the        detector positioned at a center of circle, and the three light        sources positioned anywhere upon the arc of a sector whose        circle center is the said detector; and    -   a microprocessor for receiving the signals from the detector and        calculating the signal to obtain a result value.

Another aspect of the present invention provides a method for testing anassay, which comprises:

-   -   positioning a test strip, having a test zone, a control zone and        a reference zone, in relation to an electronic assay apparatus,        the apparatus comprises a first light source, a second light        source, a third light source and only one detector;    -   receiving an assay sample;    -   measuring the light level received by the detector;    -   determining, using a microprocessor and based on the light        level, a result of the assay performed on the test strip, and    -   displaying the result of the assay;    -   wherein:    -   the first light source is aligned for illuminating light        incident upon the test zone of the test strip;    -   the second light source is aligned for illuminating light        incident upon the control zone of the test strip;    -   the third light source is aligned for illuminating light        incident upon the reference zone of the test strip;    -   the detector is so positioned as to receive light reflected from        the test zone, the control zone and the reference zone        alternately, wherein the detector and the first, the second and        the third light sources are arranged within a fan-shaped region;        the detector positioned at a center of circle, and the three        light sources positioned anywhere upon the arc of a sector whose        circle center is the said detector; and    -   the microprocessor compares the result to a threshold and        generates an output signal, if the result value exceeds the        threshold and indicative of a first value, or, alternatively,        the output signal indicative of a second signal if the result        value is less than the threshold.

In a preferred embodiment in accordance with the present invention, theresult obtained from the microprocessor which compares the light levelreceived from the test zone and the reference zone.

The method in accordance with the present invention preferably furthercomprises comparing the light level received from the control zone andthe reference zone before the result determination, for determining ifthe test strip works normally.

In a preferred embodiment in accordance with the present invention, thetest strip further comprises a second test zone for detecting adifferent analyte or a different concentration of a single analyte withthe test zone, and the electronic assay apparatus further comprises afourth light source illuminating light incident upon the second testzone.

Another aspect, the present invention provides a pregnancy testing kitcomprises the said apparatus and a plurality of test strips.

The word “the same distance” throughout the present invention means thesame distance actually or the distance within an acceptable error rangeof the electronic elements.

The word “light source” throughout the present invention means thedevice that illuminates visible light, preferably is a LED. The lightsource is preferably with a more efficiency for working, preferred agreen light, a blue light or a yellow green light.

The word “fan-shaped” throughout the present invention means the rangeof a sector whose circle center is a detector drawn with any longradius. For example, the fan-shaped can be a semicircle or a sector. Thecentral angle formed by two radii of the sector is less than, equal toor more than 180°.

The word “light level” throughout the present invention means thereflected light or the transmitted light. The reflected light means thatthe light emitted from the light source and transferred to the detectorby the test strip or other liquid, and in this circumstance, thedetector and the light source deposited in the same side. Thetransmitted light means that the light passing through the test stripand usually the detector and the light source deposited in the differentsides.

The word “change of electronics” throughout the present invention meansany kind of change could be determined by the electronics, for example,the changes of the current, the voltage or the resistivity, etc.,preferred is the change of the current or the voltage.

The skilled methods in accordance with the present invention providesimple structure, light sources with lower efficiency for working and adetector, and achieve the objective of accurate result determinations.Furthermore, this could lower the manufacture cost through the simpleposition disposition of the light sources and the detector and combinesimple structure of test strips to obtain accurate results.

The electronic assay apparatus and method in accordance with the presentinvention has following advantages.

1. The electronic assay apparatus in accordance with the presentinvention comprises at least three light sources and only one detector,and the simple structure of the apparatus can decrease the manufacturingcost.

2. The electronic assay apparatus in accordance with the presentinvention is designed to arrange the only one detector and the threelight sources within the fan-shaped range; the three light sourcespreferably positioned anywhere upon the arc of the sector whose circlecenter is the detector; this may not only decrease structure complexitybut decrease the use of the test strips and then decrease themanufacturing cost.

3. The electronic assay apparatus in accordance with the presentinvention achieve the objective of reading result values through simplelight sources and only one detector cooperating with simple algorithms.

4. The operative method of the electronic assay apparatus in accordancewith the present invention does not need to additionally detect the flowvelocity of the sample so it can decrease processing step to decreasedetermination complexity and achieve an accurate measurement.

5. The operative method of the electronic assay apparatus in accordancewith the present invention compares the result value to only onethreshold so the operational process is simple and decreases thecalculating complexity.

6. The electronic assay apparatus in accordance with the presentinvention employs green light, blue light or yellow green light todetect red color for decreasing noise compared with red light to detectblue color.

7. The pregnancy test kit employed in the present invention comprisesone electronic assay apparatus and a plurality of test strip sets forusers reusing the electronic assay apparatus conveniently and alsosaving the costs of users.

8. The electronic assay apparatus in accordance with the presentinvention is designed with a plurality of shelters and openings, theopenings corresponding to the light sources preferably have the sameshape and/or size; by this, in the preferred embodiment of the presentinvention, the light sources does not only have the same distance to thedetector but the openings is corresponded with the same shape and/orsize, to achieve the objective of precise measurements.

9. In a plurality of light sources of the electronic assay apparatus inaccordance with the present invention, the light emitted from each lightsource upon the detector has the same distance for decreasing thedeviation between the light sources and then increasing the accuracy ofthe measurement.

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an electronic assay apparatus inaccordance with the present invention.

FIG. 2 is a perspective exploded view of the electronic assay apparatusof FIG. 1 in accordance with the present invention.

FIG. 3 is a perspective view of a baffle of the electronic assayapparatus in accordance with the present invention.

FIG. 4A is a perspective view of a test strip set in accordance with thepresent invention.

FIG. 4B is a perspective view of certain internal components showing ofthe test strip set in accordance with the present invention.

FIG. 4C is a perspective exploded view of the test strip set inaccordance with the present invention.

FIG. 5 is an illustration of showing an embodiment of one arrangement ofthe electronic assay apparatus of FIG. 1 and the certain internalcomponents of the test strip set of the FIG. 2 in accordance with thepresent invention.

FIGS. 6 to 8 are cross-sectional views with different angle of thecorresponding positions between a baffle, light sources and a detectorwithin the electronic assay apparatus of FIG. 1 in accordance with thepresent invention.

FIGS. 9A to C are preferred flow chart illustrating a method of readingan assay result of the electronic assay apparatus of FIG. 1 inaccordance with the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to FIGS. 1 and 2, they are respectively represent aperspective view and a perspective exploded view of a preferredembodiment of an electronic assay apparatus in accordance with thepresent invention, the apparatus comprises a cover (10) and a circuitboard (14), more preferably, further comprises a baffle (16) and anejective element (18).

The cover (10) is preferably fabricated by a substance which is lighttight and leak less, and designed to allow the least ambient lightpassing through only. The cover (10) comprises an inserting opening(112) for inserting a test strip set (20). Furthermore, the cover (10)comprises a top cover (11) and a bottom cover (12) connected together toappear the inserting opening (112). The top cover (11) further comprisesa display (110) for displaying an assay result through differentsymbols, numbers, words or patterns, etc., for example, “+”, “−”,“positive”, “negative”, “smile face”, “cry face”, “green” or “red”, andso forth. In a pregnancy test, the method of displaying could also be“pregnant” or “not pregnant”, etc., and the present invention is notlimited to the methods said above.

With reference to FIGS. 4A to 4C, a preferred embodiment of a test stripset (20) in accordance of the present invention is used to detect aninterested analyte with the electronic assay apparatus. The test stripset (20) is used to detect pregnancy, ovulation, urine and poison test,and so on, and the sample could be urine, sweat, blood, saliva and/orother body fluid. The test strip set (20) comprises a test strip (22)with a housing. The housing comprises a bottom housing (24), a tophousing (26) and a lid (28). The bottom housing (24) and the top housing(26) connected together and the lid (28) covers one end of the connectedbottom housing (24) and top housing (26) to wrap the test strip (22).The test strip set (20) may not comprise the housing and the presentinvention is not limited to this. Please referred to FIG. 4B, the teststrip (22) comprises a first test zone (220) and a control zone (222)separated a distance to the first test zone (220). The control zone(222) reflects whether the test strip (22) is working normally and thefirst test zone tests a presence of an interested analyte.

In a preferred embodiment of the present invention, the test strip set(20) further comprises a second test zone (221) which could also be usedto detect a presence of an interested analyte. Preferably, the firsttest zone (220) and the second test zone (221) are used to detectdifferent analytes or different concentrations of an analyte. The teststrip (22), moreover, further comprises a reference zone (223) to beused when cooperates with the electronic assay apparatus, the detailedprinciple and method will be described hereinafter. The arranged methodof the first test zone (220), second test zone (221) and control zone(223) is not limited to the illustration of FIG. 4B. The positions ofthe first test zone and the second test zone could be changed to eachother, and the control zone is preferably deposited on the downstream ofthe sample pad. The top housing (26) further comprises a window (260)for corresponding to and showing the first test zone (220), the secondtest zone (221) and the reference zone (223).

Please referred to FIGS. 2 and 5, the electronic assay apparatus of thepresent embodiment utilizes to receive the reflected light as anillustration, and the present invention is not limited to this. Thecircuit board (14) comprises a first light source (140), a detector(142), a second light source (144) and a third light source (146). In apreferred embodiment of the present invention, the circuit board (14)further comprises a fourth light source (148) when the test strip set(20) has a second test zone (221). The first light source (140), thesecond light source (144), the third light source (146) and the fourthlight source (148) deposited on the circuit broad (14) for illuminatinglight to the first test zone (220), the control zone (222), thereference zone (223) and the second test zone (221) respectively.Preferably, the first light source (140), the second light source (144),the third light source (146) and the fourth light source (148) arecapable of emitting a green light, a blue light or a yellow green light.These light have more efficiency for working.

The detector (142) is deposited between the first light source (140),the second light source (144), the third light source (146) and thefourth light source (148) for detecting the reflected light from thefirst test zone (220), the second test zone (221), the control zone(222) and the reference zone (223) and transferring signals responsiveto the reflected light therefrom. In a preferred embodiment of thepresent invention, the first light source (140), the second light source(144), the third light source (146) and the fourth light source (148)respectively have the same distance to the detector (142). Preferably,the same distances said above means actually the same or with adeviation within an acceptable range of the electronic elements. Becauseof the same distance between the light sources and the detector (142),the routes of the light illuminating incident upon the responsive zonesemitted from the respective light sources and reflecting to the detector(142) are also the same. The deviation results from the differentdistances of the emitted light from the light sources received by thedetector (142) may be reduced through the aforesaid way. Only onedetector (142) may avert correction steps, for example, if a design withtwo detectors, a deviation is generated between the two detectors, andthe reflected or transmitted light detected by the two detectors areunequal and then results in the erroneous determination, so that needsto implement a correction step. The design according to the presentinvention with only one detector could avert said correction step andreduce the deviation generation.

The detector and the three light sources in accordance with the presentinvention is designed to be arranged within a fan-shaped region, thedetector positioned at a center of circle, and the three light sourcespositioned anywhere upon the arc of a sector whose circle center is saiddetector. By this way, the width of the test strip (20) could bedecreased, the cost could be reduced, receive the reflected light fromthe respective zones equally, and reduce the deviation generation toobtain a more accurate result.

The light sources preferred in this embodiment are LEDs, and thedetector could also be used to detect transmitted light. The reflectedlight means that the light emitted from the light source and transferredto the detector by the test strip or other liquids, and in thiscondition, the detector and the light source deposited in the same side.The transmitted light means that the light passing through the teststrip and usually the detector and the light source deposited in thedifferent sides. For achieving the objective of receiving the reflectedlight, the test strip usually utilizes a layer of white substances withthe reflective ability, so that, even if a part of light may passthrough the test strip, that may be reflected by the reflectivesubstance.

Further referring to FIG. 5, it is a preferred embodiment of therelative positions between the circuit board and the test strip inaccordance with the present invention. The embodiment having two testzones is an example for illustrating, but the present invention is notlimited to this. When a test strip (22) is inserted into the apparatus,every light sources (140, 144, 146, 148) are aligned with the respectivezones of the test strip (22). The first light source (140) is alignedwith the first test zone (220), the second light source (144) is alignedwith the control zone (222), the third light source (146) is alignedwith the second test zone (221) and the fourth light source (148) isaligned with the reference zone (223). The only one detector (142)detects the light reflected from the four zones and generates thecorresponding electronic changes. Preferably, the electronic change maybe a current or a voltage, the magnitude of which is proportional to thereflected light detected by the detector (142). The current is convertedto a voltage and transferred into an analogue to digital converter (AD)(not shown). The resulting digital signal is received by amicroprocessor (not shown).

The microprocessor switches on the light sources (140, 144, 146, 148)one at a time, so that only one of the zones is illuminated at any giventime.

Furthermore, the circuit board (14) in accordance with the presentinvention preferably further comprises a switch (149) electricalconnected to the microprocessor. The switch (149) will be closed whenthe test strip (22) is inserting into the apparatus and controlled bythe ejective element (18) described later, and which activates themicroprocessor.

Please referred to FIG. 3 and FIGS. 6 to 8; FIG. 3 is a preferredembodiment of a baffle at another side of the electronic assay apparatusaccording to the present invention, the baffle (16) connected with thecircuit board (14) and comprises a plurality of shelters (160) defininga plurality of openings (161, 163, 165, 167, 169) corresponding to thelight sources (140, 144, 146, 148) and the detector (142) in turn. Theplurality of shelters comprise an outer shelter (162) and an innershelter (164) respectively. The outer shelters are defined respectivelycorresponding to outside of the light sources (140, 144, 146, 148) andthe detector (142) to block light source from outside. The innershelters corresponding formed inside of the light sources (140, 144,146, 148) and the detector (142) to avoid the interference between thelight sources. In a preferred embodiment according to the presentinvention, the outer shelter connected with the inner shelter to formenclosures of the plurality of openings (161, 163, 165, 167, 169)respectively. In a preferred embodiment according to the presentinvention, the openings (161, 163, 165, 167, 169) corresponding to thelight sources (140, 144, 146, 148) have the same size and/or shape, theshape may be any suitable shape, more preferably is round or rectangle,but it is not limited to this.

The baffle (16) further comprises a blocker (166) defined upsidecorresponding to the detector (142) for blocking direct light from thelight sources (140, 144, 146, 148), and cooperated with the shelters todefine a plurality of slits. The plurality of slits permit the detector(142) to detect the reflected light from the first test zone (220), thesecond test zone (221), the control zone (222) and the reference zone(223).

The ejective element (18) connected with the baffle (16) posited withinthe cover (10). In the beginning, the test strip set (20) locks with theejective element (18) when the test strip set (20) inserts into theapparatus and then the ejective element (18) closes the switch (149) toactivate the microprocessor. After the test done, push the ejectiveelement (18) to let the test strip set (20) leave out of the ejectiveelement (18) and then the switch (149) is opened to inactivate themicroprocessor and the apparatus will shut down.

Please referred to FIGS. 9A to C, and reference to FIGS. 2 and 4. Theseare operation diagrams of the preferred embodiment illustrating theejective element (18) activating the microprocessor.

The test strip set (20) further comprises a first guiding element (29)(as shown in FIG. 4), and the ejective element (18) further comprises asecond guiding element (180). The first guiding element (29) connectedwith the second guiding element (180) for permitting the test strip set(20) fixed in the apparatus. The methods of the connection of the firstguiding element (29) and the second guiding element (180) are notlimited, for example, the first guiding element (29) is a notch and thesecond guiding element (180) is an elastic snap, the elastic snap locksinto the notch to fix the test strip set (20) when the test strip set(20) inserts into the apparatus. Further, for example, the first guidingelement (29) is a flange and the second guiding element (180) is aconcave, the test strip set (20) fixed within the apparatus after theflange connected with the concave. Further, for example, the secondguiding element (180) is a sliding groove with a shoulder and the firstguiding element is an enlargement, the enlargement may move along thesliding groove and fix at the shoulder.

The ejective element (18) may further comprise an elastic element (182)assembled within the ejective element (18). Before the test strip set(20) inserting into the electronic assay apparatus, the sectional viewof the lateral of the apparatus is referred to FIG. 9A. The test stripset (20) compresses the elastic element (182) to lock the first guidingelement (29) with the second guiding element (180), and then the teststrip set (20) fixed within the apparatus when the test strip set (20)inserts into the electronic assay apparatus (as shown in FIG. 9B), andthe test strip set (20) will compress the baffle (16) to contact theswitch (149) of the circuit board (14) at this time. In a preferredembodiment according to the present invention, the baffle (16) furthercomprises a trigger (168), the test strip set (20) compresses thetrigger (168) of the baffle (16) to permit the trigger (168) contactingthe switch (149). Preferably, the trigger (168) is an elastic piece witha convex protruded from the both side of the elastic piece, the switch(149) is contacted through compressing the convex.

Pushing the ejective element (18) to disconnect the first guidingelement (29) of the test strip set (20) and the second guiding element(180) of the ejective element (18) after the test strip set (20) used,and ejecting the test strip set (20) out of the electronic assay elementthrough the resilience of the elastic element (182) as shown in FIG. 9C.

In a further preferred embodiment, the electronic assay apparatus inaccordance with the present invention further comprises a power source(19) (as shown in FIG. 2, there is a button cell).

In a preferred embodiment according to the present invention, hereutilizing a single test zone as an example for illustrating and thepresent invention is not limited to this. The test strip (22) isemployed for pregnancy testing and comprises a sample pad (224), aconjugated pad (225), a reaction membrane (226) and an absorbent pad(227) (as shown in FIG. 4B). The conjugated pad (225) comprisesmobilized mAb (mouse antibody) anti-Beta hCG conjugated with colloidalgold. The first test zone (220) and the control zone (222) are disposedwithin the reaction membrane (226). The test zone (220) comprises avertical line of an antibody to hCG, preferably is an immobilized goatanti-Alpha hCG, and the control zone (222) comprises immobilized goatanti Mouse IgG When a sample is received from the sample pad (224), itwill pass through the conjugated pad (225) to bring the mobilized mAbanti-Beta hCG conjugated with colloidal gold, and then pass through thereaction membrane (226) to reaction. If hCG exists in the sample, hCGcombined with the mAb anti-Beta hCG conjugated with colloidal gold andcombined with the immobilized goat anti-Alpha hCG to form a sandwichAg-Ab complex and display the red color. Whether the sample contains hCGor not, the mobilized mAb anti-Beta hCG will combine with the goat antiMouse IgG at the control zone (222) to check whether the test isworkable.

Since the test strip (22) uses the red colloidal gold, the apparatusshould employ a green, blue or yellow green light source, and therefore,it can decrease the noise signals compared with red light sourceilluminating blue color on the test strip as conventional used.

The microprocessor receives the reflected light signals from the testzone, the reference zone and the control zone detected by the detector,and then compares the signals from the test zone and the control zonewith the signal from the reference to obtain a first result value and asecond result value respectively. Comparing the second result value witha predetermined threshold, when the second result value exceeds thethreshold means the test strip works normally. If the second value isless than the threshold means the test strip may have some problems, andit can also display an erroneous signal to warn the users. The firstresult value is compared to the predetermined threshold; it will show apositive result when the first result value exceeds the predeterminedthreshold, alternatively, it will indicate a negative result when thesaid value is less than the predetermined threshold.

According to a preferred embodiment of the present invention, theelectronic assay apparatus is for pregnancy testing and the sample isurine. Preferably, the threshold is responsive to samples of urinecontaining hCG of a concentration of 25 mIU/ml. Since the apparatusaccording to the present invention detects the reflected light from thetest zone, the result value lower than the threshold means the samplecontains hCG higher than 25 mIU/ml.

In another preferred embodiment in accordance with the presentinvention, wherein the test strip has more than two test zones fordetecting various items. Such as poison test, the detecting item of theeach test zone is selected from the group consisting of Cocaine (COC),Tetrahydrocannabinol (THC), Methamphetamine (MET), Amphetamine (AMP),Ecstasy (MDMA), Morphine (OPI), Phencyclidine (PCP), Benzodiazepines(BZD), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants(TCA), Oxycodone (OXY) and the combination thereof.

All of the above items can combine freely, besides MET and AMP. Becauseof their similar structures, MET and AMP will interfere with each otherand they can not be determined at the same test strip.

In the determination, the sample such as urine is absorbed into the teststrip from the sample pad and passes through the test zone with variousdetecting items. The test zone will generate a color when the samplecontains the detecting item, and then displaying the result measured bythe electronic assay apparatus.

In a preferred embodiment of the present invention, a pregnancy testingand/or ovulation kit is provided. The pregnancy testing and/or ovulationkit comprises one electronic assay apparatus and a plurality of teststrip sets for reusing the electronic assay apparatus.

Other embodiments of the invention will appear to those skilled in theart from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples to be considered as exemplary only, with a true scope andspirit of the invention being indicated by the following claims.

What is claimed is:
 1. An electronic assay apparatus for determining ananalyte within a sample through an assay performed on a test strip, theapparatus comprising: a circuit board; at least two light sourcesarranged on the circuit board for respectively illuminating lightincident upon at least two zones of a test strip; a detector configuredto detect the light from the at least two light sources and obtaincorresponding signals, wherein the detector is disposed on a location ofthe circuit board where the location is corresponding to an inside areaof the test strip and along with a long edge of the test strip when thetest strip inserted in the electronic assay apparatus, wherein distancesbetween the detector and the at least two light sources respectively arealmost the same; a baffle structure connected with the circuit board forholding the test strip, comprising: a blocker disposed corresponding toan upside of the detector for blocking direct light from the lightsources; and a plurality of shelters blocking interferences between thelight sources and defining a plurality of openings such that each of thelight sources and the detector respectively corresponds to one of theopenings, wherein a plurality of slits are defined between the blockerand the shelters for permitting the detector to detect light reflectedfrom the test strip; and a microprocessor for receiving thecorresponding signals from the detector and calculating the signals to aresult value; wherein the number of detector on the circuit board is nomore than one, and routes of light emitted from the respective lightsources, incident upon the test strip and then reflected to the detectorare almost the same.
 2. The apparatus as claimed in claim 1, wherein themicroprocessor is configured to compare the result value to a thresholdand generates an output signal, the output signal indicative of a firstresult is generated if the result value exceeds the threshold, and theoutput signal indicative of a second result is generated if the resultvalue is less than the threshold.
 3. The apparatus as claimed in claim1, wherein the microprocessor is configured to switch on one of the atleast two light sources at a time so that only one of the at least twozones on the test strip is illuminated at any given time.
 4. Theapparatus as claimed in claim 1, further comprising a cover comprising atop cover and a bottom cover connected together to form an insertingopening for inserting the test strip, and the top cover comprising adisplay.
 5. An electronic assay apparatus, comprising: a circuit board;at least four light sources arranged on the circuit board forrespectively illuminating light incident upon at least four zones of atest strip; a detector configured to detect the light from the at leastfour light sources and obtain corresponding signals, wherein thedetector is disposed on a location of the circuit board where thelocation is corresponding to an inside area of the test strip and alongwith a long edge of the test strip when the test strip inserted in theelectronic assay apparatus; a baffle structure connected with thecircuit board for holding the test strip, comprising: a blocker disposedcorresponding to an upside of the detector for blocking direct lightfrom the light sources; and a plurality of shelters blockinginterferences between the light sources and defining a plurality ofopenings such that each of the light sources and the detectorrespectively corresponds to one of the openings, wherein a plurality ofslits are defined between the blocker and the shelters for permittingthe detector to detect light reflected from the test strip; and amicroprocessor for receiving the corresponding signals from the detectorand calculating the signals to a result value; wherein the number ofdetector on the circuit board is no more than one, wherein distancesbetween the detector and the at least four light sources respectivelyare almost the same and routes of light emitted from the respectivelight sources, incident upon the test strip and then reflected to thedetector are almost the same.
 6. The apparatus as claimed in claim 5,wherein the location of the detector on the circuit board iscorresponding to an inside rectangular area of the test strip and alongwith a long edge of the rectangular area of the test strip when the teststrip inserted in the electronic assay apparatus, wherein two shortedges of the rectangular area are constructed by the at least two zonesof the test strip and the other two zones are positioned within therectangular area.
 7. The apparatus as claimed in claim 5, wherein the atleast two light sources of the four light sources are configured torespectively illuminate a first test zone and a second test zone whereare spatially separated on the test strip, and the first test zone andthe second test zone are configured to detect different type of analyteor detect different concentrations of a single analyte.
 8. The apparatusas claimed in claim 5, wherein the microprocessor is configured toswitch on one of the at least four light sources at a time so that onlyone of the at least four zones is illuminated at any given time.
 9. Theapparatus as claimed in claim 5, wherein the at least four zones includea first test zone, a control test zone, a second test zone and areference zone, and the at least four light sources include a firstlight source for illuminating light incident upon the first test zone, asecond light source for illuminating light incident upon the controlzone, a third light source for illuminating light incident upon thereference zone, and a fourth light source for illumination the secondtest zone.
 10. The apparatus as claimed in claim 5, further comprising acover comprising a top cover and a bottom cover connected together toform an inserting opening for inserting the test strip, and the topcover comprising a display.
 11. An assay test kit for determining ananalyte within a sample through an assay performed on a test strip, theassay test kit comprising: a test strip set comprising the test strip;and an assay apparatus comprising a circuit board; at least three lightsources arranged on the circuit board for respectively illuminatinglight incident upon at least three zones of the test strip; a detectorconfigured to detect the light from the at least three zones of the teststrip and obtain corresponding signals proportional to the analyte,wherein the detector is disposed on a location of the circuit boardwhere the location is corresponding to an inside area of the test stripand along with a long edge of the test strip when the test stripinserted in the electronic assay apparatus; a baffle structure connectedwith the circuit board for holding the test strip, comprising: a blockerdisposed corresponding to an upside of the detector for blocking directlight from the light sources; and a plurality of shelters blockinginterferences between the light sources and defining a plurality ofopenings such that each of the light sources and the detectorrespectively corresponds to one of the openings, wherein a plurality ofslits are defined between the blocker and the shelters for permittingthe detector to detect light reflected from the test strip; and amicroprocessor for receiving the signals from the detector andcalculating the signals to a result value; wherein the number ofdetector on the circuit board is no more than one, and routes of lightemitted from the respective light sources, incident upon the test stripand then reflected to the detector are almost the same.
 12. The kit asclaimed in claim 11, wherein the test strip set further comprises abottom housing, a top housing and a lid, the bottom housing and the tophousing are connected together, the lid covers one end of the connectedbottom housing and the top housing so as to wrap the test strip, and thetop housing includes a window to expose the at least three zones,wherein the detector is disposed on a location of the circuit boardwhere the location is corresponding to an inside area of the window andalong with a long edge of the window when the test strip inserted in theelectronic assay apparatus.
 13. The kit as claimed in claim 11, whereinthe at least three zones of the test strip include a first test zone, acontrol test zone and a reference zone, and the first test zonecomprises a first immobilized substance that is configured to react witha first analyte, and the at least three light sources include a firstlight source for illuminating light incident upon the first test zone, asecond light source for illuminating light incident upon the controlzone, and a third light source for illuminating light incident upon thereference zone.
 14. The kit as claimed in claim 13, wherein the teststrip further includes a second test zone spatially separated with theat least three zones of the test strip, the second test zone comprises asecond immobilized substance that is configured to react with a secondanalyte, the assay apparatus further includes a fourth light source forilluminating light incident upon the second test zone, and the secondanalyte is the same as or different from the first analyte.
 15. The kitas claimed in claim 11, wherein the assay test kit is used for pregnancyand/or ovulation testing.
 16. The kit as claimed in claim 11, whereinthe test strip comprises a sample pad for receiving the sample, aconjugated pad comprising a mobilized substance conjugated withcolloidal gold, a reaction membrane and an absorbent pad, the at leastthree zones of the test strip are arranged on the reaction membrane. 17.The kit as claimed in claim 16, wherein the at least three light sourcesare configured for illuminating green, blue or yellow green light. 18.The kit as claimed in claim 16, wherein the test strip set comprises abottom housing and a top housing that are connected together to wrap thetest strip, and at least a portion of the sample pad is exposed from theconnected bottom housing and the top housing, and a lid configured tocover the exposed portion of the sample pad.
 19. The kit as claimed inclaim 18, further comprising an ejective element for positioning orejecting the test strip set, and a switch electrical connected to themicroprocessor, wherein the ejective element is configured to lockingthe test strip set when the test strip set inserted for operativelyopening the switch that activates the microprocessor and turns the assayapparatus on.
 20. The kit as claimed in claim 19, wherein the bafflefurther comprises a trigger made by elastic piece configured to becompressed by the test strip set for contacting the switch to be an openstate.